Healthcare Law Compliance Program
Medicines360's mission is to expand access to medicines for women regardless of their socioeconomic status, insurance coverage, or geographic location. In pursuing its mission, Medicines360 strives for a high standard of corporate conduct and is committed to establishing and maintaining an effective and comprehensive corporate compliance program. As a part of this effort, we have adopted a compliance program that addresses the matters covered by the May 2003 publication "Compliance Program Guidance for Pharmaceutical Manufacturers" ("OIG Guidance"), which was developed by the United States Department of Health and Human Services Office of Inspector General ("OIG"). The OIG Guidance gives broad discretion to manufacturers in the development, design and definition of scope of a compliance program.
Medicines360 Healthcare Law Compliance Program may be referred to as our "Compliance Program" throughout this description. Our Compliance Program applies to our Board of Directors, officers, employees, contractors and consultants in their activities on behalf of Medicines360 and its subsidiaries (collectively referred to as “Company Representatives”).
Our Compliance Program's purpose is to assist Medicines360 in maintaining compliance with the laws, regulations and company directives and guidance that apply to the commercialization of our products, to train Company Representatives on these matters and to prevent, detect, and correct instances of non-compliance. Medicines360 expects Company Representatives to comply with all applicable Medicines360 directives and guidance relating to the commercialization of our products, as well as the related laws and regulations that apply to our commercialization activities. In the event that Medicines360 becomes aware of non-compliance relating to the commercialization of our products, we will investigate the matter and, where appropriate, take disciplinary action, up to and including personnel termination, and implement corrective measures to prevent future non-compliance.
Medicines360's Compliance Program is described below. Our Compliance Program is dynamic; we intend to regularly review and modify our Compliance Program to meet our evolving compliance needs. Accordingly, the Compliance Program may be amended or revised by Medicines360 from time to time.
1. Leadership and Structure
Medicines360's Chief Compliance Officer (or Head of Compliance) has overall responsibility for oversight of Medicines360's Compliance Program. This includes oversight of the development and operation of the Compliance Program. The Chief Compliance Officer has been vested with the authority relating to compliance regarding commercialization matters within the organization and shall exercise independent judgment concerning these matters. In this role, the Chief Compliance Officer reports directly to the Chief Executive Officer and makes reports to the Board of Directors concerning operation of the Compliance Program.
2. Written Standards
Medicines360 has implemented a Code of Business Conduct which helps guide our daily operations in the commercialization arena and reflects the unique business and regulatory environment in which we operate. Our Code of Business Conduct reflects our consideration of the OIG Guidance.
3. Annual Spending Limit
Medicines360 also has established guidance regarding appropriate interactions with health care professionals. It is Medicines360's policy to comply with the Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on Interactions with Health Care Professionals," dated July 2008, which includes limits on gifts, meals and other activities with health care professionals.
For purposes of complying with the California Health and Safety Code 119402, Medicines360 has established, commencing July 1, 2015, a maximum annual aggregate dollar limit of $1,500 for gifts, promotional materials, items or activities provided to an individual California health care professional. This dollar limit represents a spending cap, not a goal or average, and typically the amount spent per physician is anticipated to be substantially less than this maximum amount.
To attempt to assure that health care professionals ("HCPs") fully understand our products, Medicines360 representatives may take time to explain the benefits and risks associated with them, as well as the relevant clinical efficacy studies and mechanisms of action, where appropriate. Some of these informational and educational presentations may take place over the course of a modest meal to avoid taking HCPs away from important time with their patients.
On occasion, Medicines360 may provide medically-relevant and patient-oriented items to HCPs that conform to the PhRMA Code. Some examples may include anatomical models, patient education charts and information that is useful for patients in understanding or managing their condition and/or treatment.
4. Education and Training of Medicines360 Staff
A critical element of our Compliance Program is education and training. Medicines360 is committed to implementing programs to communicate our directives and guidance to affected personnel in an effective and timely manner. New personnel will receive such training as part of their onboarding and existing personnel receive compliance training on at least an annual basis. Moreover, Medicines360 will review and update its training programs periodically, as well as identify additional areas of training on an ongoing basis.
5. Internal Lines of Communication
We expect Medicines360 Representatives to promptly report suspected, planned or actual violations of our commercially-related directives and guidelines and/or laws which govern our commercialization activities. We encourage reports to be made to a supervisor, manager, or directly to the Chief Compliance Officer. If these individuals are not available or if the reporter prefers, reports of violations, including those from outside the company, may be made on an anonymous basis via Ethicspoint, Medicines360's Compliance and Ethics third party provider. The toll-free Ethicspoint Hotline is available 24 hours a day, 7 days a week at (844) 239-0562. Individuals may also file an anonymous report via the online portal, which can be accessed at http://medicines360.ethicspoint.com.
We also encourage Company Representatives to ask questions about any activity where they are unclear about a potential violation or application of our Compliance Program. Questions may be posed through any of the established channels described above.
Medicines360 supports an “open door” policy for all Company Representatives, ensuring non-retaliation and upholding confidentiality where necessary and/or appropriate.
Acts of retaliation or retribution against an employee or officer who in good faith reports a potential, suspected, planned or actual violation or application of our directives and guidelines and/or laws which govern our commercialization activities are not permitted and will be dealt with appropriately.
6. Auditing and Monitoring
It is a role of the Chief Compliance Officer to develop a plan for auditing and monitoring compliance with Medicines360's Compliance Program and the implementation of related directives and guidelines. These audits are intended to identify potential or existing problem areas and to take corrective measures in an effort to prevent the recurrence of non-compliance. The nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices and other considerations.
7. Responding to Potential Violations
An additional role of the Chief Compliance Officer, or a designee, is to oversee the review of non-compliance reports and determine whether further investigation is necessary. Audit findings also are reported to the Chief Compliance Officer. The Chief Compliance Officer has oversight of the investigation of any alleged compliance and ethics violations. When deemed necessary, the Chief Compliance Officer, or a designee, will conduct an investigation into potentially non-compliant activity to determine whether a violation of the Compliance Program has occurred. As necessary to evaluate a report, audit findings, or to undertake further investigation, the Chief Compliance Officer may request the assistance of outside experts or legal counsel.
8. Corrective Action Procedures
Another role of the Chief Compliance Officer is to oversee the implementation of corrective measures in response to non-compliance with Medicines360's Compliance Program. Corrective measures take into account the findings of reviews of non-compliance, and may include appropriate and consistent disciplinary action regardless of the individual's position within the organization (up to and including termination), assessing whether enhancements should be made to our policies, practices, training, or internal controls, and taking action to prevent future non-compliance.
In appropriate circumstances, the Chief Compliance Officer will report instances of noncompliance to law enforcement authorities.
Medicines360 is committed to compliance and continually strives to monitor and improve the company's compliance with the Compliance Program.
As part of Medicines360's continuing commitment to corporate compliance, Medicines360 declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code sections 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. As of the date of this declaration, Medicines360 believes it is in compliance with its Healthcare Law Compliance Program in all material respects.
Consistent with Medicines360's understanding of the California statute, this declaration is limited to those activities undertaken by Medicines360 that are directed to California. Medicines360 makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design, and definition of the scope of compliance programs.
Copies of this declaration and the Healthcare Law Compliance Program may be obtained by calling our toll-free number at (844) 239-0562.
Dated: June 6, 2017